Clinical trial • Phase III • Oncology

PATRITUMAB DERUXTECAN for Hormone receptor positive HER2-negative breast cancer | Hormone receptor positive breast cancer

Phase III trial of PATRITUMAB DERUXTECAN for Hormone receptor positive HER2-negative breast cancer | Hormone receptor positive breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hormone receptor positive HER2-negative breast cancer | Hormone receptor positive breast cancer
Trial Stage
Phase III
Drug Modality
ADC | Small molecule

Key dates

Initial CTIS Submission Date
10-06-2025
First CTIS Authorization Date
29-09-2025

Trial design

Randomised, open-label, physician’s choice (tpc) comparator options listed in part i: doxorubicin hydrochloride, liposomal (product: doxorubicin hydrochloride, liposomal; route: intravenous infusion; doseuom: mg/m2; maxdailydoseamount: 50), doxorubicin hydrochloride (product: doxorubicin; route: intravenous infusion; doseuom: mg/m2; maxdailydoseamount: 50), capecitabine (product: capecitabine; route: oral use; doseuom: mg/m2; maxdailydoseamount: 2000), trastuzumab deruxtecan (product: trastuzumab deruxtecan; route: intravenous infusion; doseuom: mg/kg; maxdailydoseamount: 5.4), paclitaxel (product: paclitaxel; route: intravenous infusion; doseuom: mg/m2; maxdailydoseamount: 90), paclitaxel albumin-bound (product: paclitaxel albumin-bound; route: intravenous infusion; doseuom: mg/m2; maxdailydoseamount: 100). (no detailed schedule provided in the ctis record.)-controlled Phase III trial in Germany, Greece, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Physician’s choice (TPC) comparator options listed in Part I: DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL (product: DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL; route: INTRAVENOUS INFUSION; doseUom: mg/m2; maxDailyDoseAmount: 50), DOXORUBICIN HYDROCHLORIDE (product: DOXORUBICIN; route: INTRAVENOUS INFUSION; doseUom: mg/m2; maxDailyDoseAmount: 50), CAPECITABINE (product: CAPECITABINE; route: ORAL USE; doseUom: mg/m2; maxDailyDoseAmount: 2000), TRASTUZUMAB DERUXTECAN (product: TRASTUZUMAB DERUXTECAN; route: INTRAVENOUS INFUSION; doseUom: mg/kg; maxDailyDoseAmount: 5.4), PACLITAXEL (product: PACLITAXEL; route: INTRAVENOUS INFUSION; doseUom: mg/m2; maxDailyDoseAmount: 90), PACLITAXEL ALBUMIN-BOUND (product: PACLITAXEL ALBUMIN-BOUND; route: INTRAVENOUS INFUSION; doseUom: mg/m2; maxDailyDoseAmount: 100). (No detailed schedule provided in the CTIS record.)
Target Sample Size
771

Eligibility

Recruits 771 No vulnerable population selected (isVulnerablePopulationSelected=false).

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false)

Inclusion criteria

  • {"criterion_text":"- Has a diagnosis of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent"}
  • {"criterion_text":"- Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)"}
  • {"criterion_text":"- Must have had progression or recurrence on prior cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor + endocrine therapy (ET) with one of the following: a.\tRadiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as first line (1L) for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or b.\tDisease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor or within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor"}
  • {"criterion_text":"- Is determined by the investigator to be a candidate for at least 1 treatment of physician’s choice (TPC) option"}
  • {"criterion_text":"- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology"}
  • {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy"}
  • {"criterion_text":"- Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization"}

Exclusion criteria

  • {"criterion_text":"- Has breast cancer amenable to treatment with curative intent"}
  • {"criterion_text":"- Has ≥Grade 2 peripheral neuropathy"}
  • {"criterion_text":"- Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (e.g., T-DXd) or any other topoisomerase I inhibitor therapy"}
  • {"criterion_text":"- Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization. Participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered."}
  • {"criterion_text":"- Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention"}
  • {"criterion_text":"- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy"}
  • {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 3 years"}
  • {"criterion_text":"- Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients"}
  • {"criterion_text":"- Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients"}
  • {"criterion_text":"- Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator. Patients with alterations/mutations in phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3KCA), phosphatase and tensin homolog (PTEN), alpha-serine/threonine kinase (AKT), or estrogen receptor 1 (ESR1) who are deemed suitable for second line (2L) treatment with ET in combination with targeted therapy, where available, are not eligible"}
  • {"criterion_text":"- Has a known germline BReast CAncer gene (BRCA) mutation (deleterious or suspected deleterious) where poly adenosine diphosphate-ribose polymerase (PARP) inhibitor(s) is a potential treatment option (i.e., available and not medically contraindicated)"}
  • {"criterion_text":"- Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications"}
  • {"criterion_text":"- Has any of the following: a pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen"}
  • {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease"}
  • {"criterion_text":"- Has clinically significant corneal disease"}
  • {"criterion_text":"- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer"}
  • {"criterion_text":"- Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR (as stated in trial objectives)"}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Compare HER3-DXd to TPC with respect to OS in all participants (as stated in trial objectives)"}

Secondary endpoints

  • {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by BICR (stated in secondary objectives)"}
  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR (stated in secondary objectives)"}
  • {"endpoint_text":"- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 GHS/QoL score (instrument specified)"}
  • {"endpoint_text":"- Change from Baseline in EORTC QLQ-C30 Physical Functioning Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 physical functioning score"}
  • {"endpoint_text":"- Change from Baseline in EORTC QLQ-C30 Emotional Functioning Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 emotional functioning score"}
  • {"endpoint_text":"- Change from Baseline in EORTC QLQ-C30 Pain Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 pain score"}
  • {"endpoint_text":"- Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status-Quality of Life Score","definition_or_measurement_approach":"TTD in EORTC QLQ-C30 GHS/QoL score"}
  • {"endpoint_text":"- TTD in EORTC QLQ-C30 Physical Functioning Score","definition_or_measurement_approach":"TTD in EORTC QLQ-C30 physical functioning score"}
  • {"endpoint_text":"- TTD in EORTC QLQ-C30 Emotional Functioning Score","definition_or_measurement_approach":"TTD in EORTC QLQ-C30 emotional functioning score"}
  • {"endpoint_text":"- TTD in EORTC QLQ-C30 Pain Score","definition_or_measurement_approach":"TTD in EORTC QLQ-C30 pain score"}
  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any AE"}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to an AE"}

Recruitment

Digital Remote Recruitment
True, digital/remote methods explicitly referenced in documents: Website (Poland - Recruitment Doc Website_POL_PL), Patient Banner Ad (Germany) and Greenphire/eCOA reference (Greece: L1_ICF_Optional_Greenphire adults_GRC_EL_IN_for pub).
Planned Sample Size
771
Recruitment Window Months
93
Consent Approach
Informed consent obtained using country-specific adult main consent forms. Subject information and informed consent forms available in multiple country versions (documents list includes main consent forms in DEU, GRC/EL, POL/PL, FRA/FR, ESP/ES, ITA/IT, HUN/HU and English versions). Optional consents listed include limited screening consent, optional pregnancy follow-up, pregnant partner consent, genetic consent and data privacy addenda where applicable. No assent/children consent documents are indicated in the CTIS record.

Methods

  • Germany: Recruitment materials indicated (document titles) Patient Banner Ad; Patient Brochure; Posters (documents listed under Germany K1/K2 materials) — channel: printed/online patient-facing materials; target: patients
  • Greece: Recruitment materials indicated Patient Brochure; Poster; Master Tissue Brochure (documents under Greece K1/K2) — channel: printed/online patient-facing materials; target: patients
  • Poland: Recruitment materials indicated Website and Patient Brochure (documents include Website_POL_PL) — channel: website; target: patients
  • France: Recruitment materials indicated Poster and Patient Brochure (documents under FRA_FR) — channel: printed/online patient-facing materials; target: patients
  • Spain: Recruitment materials indicated patient-facing consent and brochures (ESP_ES documents) — channel: printed/online materials; target: patients
  • Italy: Recruitment arrangements document present (ITA_EN) — channel: country recruitment document; target: patients
  • Hungary: Recruitment materials and patient brochure indicated (HUN documents) — channel: printed/online materials; target: patients

Geography

Total Number Of Sites
48
Total Number Of Participants
211

Germany

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
54
Number Of Sites
14
Number Of Participants
50

Sites

Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Gynäkologie, Geburtshilfe und Reproduktionsmedizi
Contact Person Name
Julia Radosa
Contact Person Email
Julia.Radosa@uks.eu
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Paul Gaß
Contact Person Email
paul.gass@skc.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Contact Person Name
Peter Fasching
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Gynäkologischen Krebszentrums
Contact Person Name
Sebastian Jud
Contact Person Email
Sebastian.Jud@mutterhaus.de
Site Name
Klinikum Dortmund gGmbH
Department Name
Frauenklinik
Contact Person Name
Claudia Biehl
Contact Person Email
Claudia.Biehl@klinikumdo.de
Site Name
Diakonie in Suedwestfalen gGmbH
Department Name
Allgemeine Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Katharina Gillen
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Marion Von Mackelenbergh
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Department of Gynaecology and Obstetrics
Contact Person Name
Marc Thill
Contact Person Email
madeleine.modrow@agaplesion.de
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Universitätsklinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Contact Person Name
Atanas Ignatov
Contact Person Email
atanas.ignatov@med.ovgu.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie Charité
Contact Person Name
Verena Kiver
Contact Person Email
verena.kiver@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Sabine Heublein
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Tjoung-Won Park-Simon
Site Name
Luisenkrankenhaus GmbH & Co. KG
Department Name
Zentrum für Gynäkologische Onkologie Düsseldorf
Contact Person Name
Athina Kostara
Site Name
Klinikum Lippe GmbH
Department Name
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Beyhan Ataseven

Greece

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
99
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Athens Medical Center S.A.
Department Name
International Oncology Center- Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Areteio Hospital
Department Name
B' Surgery Clinic, Oncology Unit, National and Kapodistrian University of Athens
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine-Department of Medical Oncology, Clinical Trials Office
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
medoncsec@med.uoc.gr
Site Name
Laiko General Hospital Of Athens
Department Name
University of Athens, Oncology Department
Contact Person Name
Helen Gogas
Contact Person Email
helgogas@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
38
Number Of Sites
8
Number Of Participants
42

Sites

Site Name
Salve Medica Sp. z o.o. S.K.
Contact Person Name
Monika Kukulska
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@nio.gov.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej, Chemioterapii
Contact Person Name
Wojciech Rogowski
Contact Person Email
kopec.em@gmail.com
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Klinika Onkologii i Immunologii z Oddziałem Dziennym Terapii Onkologicznej
Contact Person Name
Monika Kotyla
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Oddział Kliniczny Onkologii
Contact Person Name
Adrianna Makarewicz
Contact Person Email
makarewicza@co.bydgoszcz.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej im. dr E. Pileckiej z pododdziałem Chemioterapii Dziennej
Contact Person Name
Kinga Hermanowicz-Szamatowicz
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej, Chemioterapii

France

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
76
Number Of Sites
4
Number Of Participants
31

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncologie
Contact Person Name
Laura Deiana
Contact Person Email
laura.deiana@chu-brest.fr
Site Name
Centre Henri Becquerel
Department Name
Oncologie
Contact Person Name
Julien Hoba
Contact Person Email
julien.hoba@chb.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Oncologie
Contact Person Name
Thomas Bachelot
Site Name
Institut Gustave Roussy
Department Name
Oncologie
Contact Person Name
Barbara Pistilli

Spain

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
42
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncología médica
Contact Person Name
Milana Bergamino Silven
Contact Person Email
bergamino@clinic.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncología médica
Contact Person Name
Cristina Reboredo Rendo
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncología médica
Contact Person Name
Maria Rodriguez de la Borbolla
Site Name
Institut Catala D'oncologia
Department Name
Oncología médica
Contact Person Name
Gaston Zatta Cobos
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncología médica
Contact Person Name
Carmen Hinojo Gonzalez
Contact Person Email
carmen.hinojo@scsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología médica
Contact Person Name
Maria Fernandez Abad
Contact Person Email
mariafernandezabad@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncología médica
Contact Person Name
Jose Angel Garcia Saenz
Contact Person Email
jgsaenz@salud.madrid.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncología médica

Italy

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
20
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Oncologia
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Clinica Sperimentale di Senologia – Senologia
Contact Person Name
Michelino De Laurentiis
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa di Oncologia Medica 1
Contact Person Name
Claudio Vernieri
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOSD Medicina di Precisione in Senologia
Contact Person Name
Alessandra Fabi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia Medica
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Hungary

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
63
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiológia
Contact Person Name
Ágnes Wéber
Contact Person Email
agneswebermd@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
B-Belgyógyászati Onkológiai Osztály
Contact Person Name
Gábor Rubovszky
Contact Person Email
rubovszky.gabor@oncol.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu
Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Contact Person Name
Júlia Lohinszky

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
PPDBioA
Responsibilities
sponsorDuties code 4 (role code list present in CTIS record)
Name
Clario
Responsibilities
sponsorDuties code 13 (role code list present in CTIS record)
Name
Almac Clinical Services LLC
Responsibilities
sponsorDuties code 3 (role code list present in CTIS record)
Name
Signant Health Global LLC
Responsibilities
Electronic Patient Reported Outcomes
Name
Labcorp Central Laboratory Services SARL
Responsibilities
central laboratory services (sponsorDuties code 4)
Name
Median Technologies
Responsibilities
Imaging
Name
Infinity Biologix LLC
Responsibilities
sponsorDuties code 4
Name
Roche Diagnostics GmbH
Responsibilities
sponsorDuties code 4

Third parties

  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"sponsorDuties codes: [13]","organisation_type":"Health care"}
  • {"country":"United States","full_name":"PPDBioA","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services) (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Electronic Patient Reported Outcomes (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-1022
Active Substance
PATRITUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus: 1
Maximum Dose
maxTotalDoseAmount: 106.4 mg/Kg (maxDailyDoseAmount: 5.6 mg/kg)

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